FDA.reportPublic FDA data

Uni-Etch w/BAC

Primary DI
10810111540992
Brand
Uni-Etch w/BAC
Company
BISCO INC.
Model
E-5662
Catalog number
E-5662
Device description
Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 30ml Syringe
Published
2022-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLEAGENT, TOOTH BONDING, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810111540992PackageGS11In Commercial Distribution
D757E56620PreviousHIBCC0
00810111540995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011154099210810111540992
00810111540995008101115409958101115409950810111540995

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(847)534-6000sales@bisco.com

Regulatory Flags#

DUNS number
053529939
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111540995Uni-Etch w/BACE-5662E-56622022-10-10
00810111541084Etch-37E-5623EE-5623E2023-01-16
00810111541138Select HV Etch w/BACE-5916E-59162022-10-11
00810111541183Select HV EtchE-5906E-59062022-10-10
D757E5632EBM1UNI-ETCH 32% w/BAC 5gm/TipsE-5632EBME-5632EBM2017-06-12
D757E5638E1ETCH-37 37% 30gm BtlE-5638EE-5638E2017-06-12
D757E56610K1Uni-Etch 32% 30ml KitE-56610KE-56610K2017-06-12
D757E56611P1Uni-Etch 32% 30ml Refill PkgE-56611PE-56611P2017-06-12
D757E56620K1Uni-Etch 32% w/BAC 30ml KitE-56620KE-56620K2017-06-12
D757E56730K1Etch-37 30ml KitE-56730KE-56730K2017-06-12
D757E56731P1Etch-37 30ml Refill PkgE-56731PE-56731P2017-06-12
D757E56740K1Etch-37 w/BAC 30ml KitE-56740KE-56740K2017-06-12
D757E570104% Porcelain Gel Etchant 7gmE-5701E-57012017-06-12
D757E570604% Porcelain Etchant 2mlE-5706E-57062017-06-12
D757E5912PS1Select HV Etch w/BAC 1g Sample Syringe PkgE-5912PSE-5912PS2017-06-12
00810111541190Select HV EtchE-59100KE-59100K2022-11-17
00810111541220Porcelain EtchantE-5701EE-5701E2022-11-17
00810111540988Uni-Etch w/BACE-5637EBE-5637EB2022-10-11
00810111541008Uni-EtchE-5622EE-5622E2022-10-11
00810111541060Etch-37 w/BACE-5638EBE-5638EB2022-10-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
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D0019064150LucitoneDentsply International Inc.KLE2025-07-01
D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
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D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14
07615208293128Adhese 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208295375Monobond Etch & PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296136Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296143Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297362ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297379ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208302684SyntacIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-03-29
10371347008729Advance Dental ProductsThe Atlanta Dental Supply CompanyKLE2022-12-29